Public Statements

Food and Drug Administration Safety and Innovation Act

Floor Speech

Mr. Speaker, I want to thank Mr. Waxman, Chairman Harkin, Senator Enzi, and Members on both sides of the aisle in both the House and the Senate who played a role in this process. S. 3187 is a reflection of the hard work put in by both Members and staff, and of everyone's willingness to put partisanship aside to look at the issues together. Because of that outstanding dedication, we have a bill today that will make a real difference in the lives of so many patients and provide much-needed support for innovators across our great country.

At the outset of this Congress, I set a goal of enacting this bill by the end of June--and here we are, well before the clock expires for this month--in order to provide certainty for American patients and innovators. I never lost confidence that we could deliver the bipartisan reforms we needed, and I am so proud that we will accomplish that goal.

Mr. Speaker, this is a jobs bill, and it's a medical innovation bill. And as we put this package together, our goal was to improve the predictability, consistency, transparency, and efficiency of FDA regulation. These reforms will help get new treatments to patients more quickly. They will help us not only keep jobs in Michigan and all across the country, but also to create new ones. In order to get it right, we turned to patients, innovators, and job creators who provided firsthand experience of how the current system is broken. And we included many of their suggestions in the bill.

This bill includes significant accountability and reform measures designed to hold the FDA responsible for its performance. The measure includes independent assessments of FDA's drug and device review process. It also includes requiring quarterly reporting from the device center so we don't have to wait a year to find out FDA's progress. The bill is about patients, and that's why so many patient advocates have spoken out in support of these reforms. Whether it is steps that we took to support treatments for rare diseases or mitigate drug shortages or speed up the approval of devices that will improve a patient's quality of life, these are steps that will make a real and significant difference.

They're going to keep the U.S. at the forefront of medical innovation where we belong.

This bill is just the first step. This bill provides the resources and the game plans so that FDA can improve its performance.

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Mr. UPTON. I yield myself an additional minute.

It is now up to the FDA to execute that game plan. And I give my commitment today that our committee will continue to monitor and hold the FDA accountable for its performance. So, together, the Members of the House and the Senate have produced a bill that is a win for American patients, innovation, and job creation.

Before I conclude, I would like to recognize Warren Burke and Megan Renfrew from the Legislative Counsel's Office for their tireless work. The role of Legislative Counsel often goes unnoticed. I also want to appreciate our staff, starting with our staff director, Gary Andres, for pushing this legislation over the finish line; Clay Alspach, on the majority staff; Rachel Sher, on the minority staff; and in particular, Ryan Long, the chief counsel for the Health Subcommittee.

This bill, when it becomes law, patients will benefit from faster, newer, and better treatments, and American workers will keep us on the cutting edge of medical innovation.

I reserve the balance of my time.

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Mr. UPTON. Thank you, Mr. Speaker.

Mr. Speaker, I just want to say that with all of the positive comments here, this bill was not a piece of cake. There was a lot of hard work on both sides of the aisle, particularly by the staff on both sides of the aisle. Again, I want to cite Clay and Ryan on our staff.

But let's face it: All of us particularly involved on the health side of the issues, as we meet with different folks afflicted with different diseases, we want to find a cure. And it would be great to find that cure here in America because we have outstanding pharmaceutical industries that have the talent and the staff to work with the different departments, whether it be the NIH, the CDC, certainly the FDA.

So we really did set out last summer to embark on a good listening session to find out what it is that we needed to do not only to find the cures and the prescriptions but the right process for them to be approved so that those companies that are willing to make that investment would stay here in America and not go overseas. Because we really do want it made in America. We have the best folks here. And that's what this bill does.

The hard work in so many of the hearings that Joe Pitts led with Mr. Pallone, the work, the amendments, the subcommittee, the full committee, that whole process to get it done before it really expired later on this year is so important not only to the workers but, more importantly, to the patients.

So dealing with the drug shortages and working with Mr. McCaul and the different rare diseases, all of those different elements, we were able to weave into what I think is a mighty fine, strong bill. And to then, of course, work with our counterparts in the Senate, whom we often bash here, but they actually stayed with us, and we were able to work in a very strong bipartisan way to get our two bills refined and done in order to bring up on the House floor this afternoon.

I want to compliment everyone--and certainly Mr. Waxman, who is back on the floor--our leadership, the team that we had on both sides of the aisle and, again, our hardworking staff that really worked so hard to get this done, which impacts millions of lives.

I urge my colleagues to support this bill, and I yield back the balance of my time.